Metastatic Pancreatic Cancer
Conditions
Keywords
Plerixafor, Cemiplimab, Immunotherapy, PD-L1 (receptor blocking antibody), Anti-PD-L1, CXCR4 (chemokine receptor), Antibodies, Metastatic pancreatic cancer
Brief summary
The purpose of this study is to evaluate the safety and clinical activity of plerixafor in combination with cemiplimab in patients with metastatic pancreatic cancer.
Interventions
DRUGCemiplimab
Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years.
DRUGPlerixafor
Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Sponsors
Genzyme, a Sanofi Company
American Association for Cancer Research
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Have histologically or cytologically-proven ductal pancreatic cancer. * Have metastatic disease. * Have documented radiographic disease progression after previous systemic chemotherapy given in a neoadjuvant, adjuvant, locally advanced or metastatic setting. * Patients with the presence of at least one measurable lesion. * Willing to have to a tumor biopsy. * Life expectancy of greater than 3 months. * Patients must have adequate organ and marrow function defined by study - specified laboratory tests. * Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol. * Men must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document.
Exclusion criteria
* Known history or evidence of brain metastases. * Had chemotherapy, radiation, or steroids within 14 days prior to study treatment. * Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment. * Require any antineoplastic therapy. * Had surgery within 28 days of dosing of investigational agent. * Has received any prophylactic vaccine within 14 days of first dose of study drug. * History of prior treatment with anti-CXCR4. * Have used any systemic steroids within 14 days of study treatment. * Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, within 14 days of study drug administration. * Hypersensitivity reaction to any monoclonal antibody. * Evidence of clinical or radiographic ascites. * Have clinically significant and/or malignant pleural effusion. * Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Has an active known or suspected autoimmune disease. * Prior tissue or organ allograft or allogeneic bone marrow transplantation. * All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\], version 5) or baseline before administration of study drug. * Infection with HIV or hepatitis B or C at screening. * Patient has a pulse oximetry of \<92% on room air. * Patient is on supplemental home oxygen. * Has uncontrolled intercurrent acute or chronic medical illness or any use of illicit drugs or substance abuse. * Patient is unwilling or unable to follow the study schedule for any reason. * Woman who are pregnant or breastfeeding. * Have rapidly progressing disease, as judged by the investigator. * History of significant, recurrent, unexplained postural hypotension in the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria | 10 months | ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) Using RECIST 1.1 Criteria | 10 months | Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. |
| Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities | 13 months | Defined using NCI CTCAE v5.0 |
Countries
United States
Participant flow
Pre-assignment details
4 participants were excluded from analysis because they did not receive at least one dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Cemiplimab and Plerixafor All participants will receive Cemiplimab and Plerixafor.
Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years.
Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Cemiplimab and Plerixafor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 21 / 21 |
| other Total, other adverse events | 21 / 21 |
| serious Total, serious adverse events | 13 / 21 |
Outcome results
Primary
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: 10 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cemiplimab and Plerixafor | Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria | 0 Participants |
Secondary
Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities
Defined using NCI CTCAE v5.0
Time frame: 13 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cemiplimab and Plerixafor | Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities | 4 Participants |
Secondary
Overall Response Rate (ORR) Using RECIST 1.1 Criteria
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.
Time frame: 10 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cemiplimab and Plerixafor | Overall Response Rate (ORR) Using RECIST 1.1 Criteria | 0 Participants |